Abstract

ADVERSE EVENTS OF DRUG TREATMENT IN 547 PEDIATRIC PATIENTS WITH RHEUMATIC AUTOIMMUNE DISEASES: A RETROSPECTIVE COHORT IN A SINGLE CENTER

Said MA, Alves GGB, Len CA, Piotto DG, Terreri MT*

Abstract

Introduction: Treatment of autoimmune rheumatic diseases (AIRDs) can cause adverse events (AEs) and the severity depends on different factors. Objectives: To describe the AEs of the medications used in the treatment of AIRDs and to report their severity, associated factors, procedures and the follow-up in patients with juvenile idiopathic arthritis (JIA), juvenile systemic lupus erythematosus (JSLE) and juvenile dermatomyositis (JDM). Methods: Retrospective descriptive and analytical study of a cohort of pediatric AIRDs. We evaluated all AEs and the aggravating factors for the AE. A regression logistic model and a multiple regression model of Poisson were set up. Results: 547 patients were included and 951 AEs were observed. MTX was the cause of the most AEs (63.3% of patients), followed by the GCs. Other immunosuppressive medications, biological agents and gammaglobulin also caused AEs. The risk of AEs to MTX and to GCs was higher in patients up to 16 years of age and who received MTX subcutaneously. In addition, the patients with JIA and JDM presented less risk of AEs to GCs than patients with JSLE. In the multiple regression model every additional month of use of GCs led to an increase of 0.5% in the mean of number of AEs. Two patients (0.2%) presented life threatening AEs. Drug withdrawal occurred in 23.9% of cases. Conclusion: This study is unique because it is the largest retrospective study in the literature, which focuses on the AEs for medications used in the treatment of childhood AIRDs in a specialized center.

Keywords: Autoimmune rheumatic diseases, adverse events, methotrexate, glucocorticoids, biological agents, childhood.